Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer [ Time Frame: At 28 days after last vaccination as compared to baseline ] [ Designated as safety issue: No ]

Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer [ Time Frame: At 6 months after last vaccination as compared to baseline ] [ Designated as safety issue: No ]

Anti-Vi ELISA Geometric Mean Concentration (GMC) [ Time Frame: At 28 days after last vaccination ] [ Designated as safety issue: No ]

Anti-Vi ELISA GMC [ Time Frame: At 6 months after last vaccination ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: October 26, 2010)

To evaluate the immunogenicity profile as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

Official Title ICMJE

A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

Brief Summary

This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

200

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Main eligibility criteria:

Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).

Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial.

Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial.

Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.

Gender

Both

Ages

6 Weeks to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects